18 completed, 7 terminated, 5 active not recruiting, 3 not yet recruiting. 24 Phase 2, 8 Phase 3, 5 Phase 1, 2 Early Phase 1, 2 Not applicable.
Follow Lupus Erythematosus, Discoid: new trials by email Literature Review of Lupus Erythematosus, Discoid trials Research Report on Lupus Erythematosus, Discoid
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE] Enpatoran - Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE) | Phase 3 | Not yet recruiting | EMD Serono Research & Development Institute, Inc. | 404 | 2026-10-15 | 2026-09-25 |
| Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus Afimetoran, Placebo - Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus | Phase 2 / Phase 3 | Not yet recruiting | Beeline Medicines Corporation | 390 | 2026-10-01 | 2026-10-28 |
| A Multicentre, Randomised, Double-blind, Positive-control Clinical Trial Evaluating Dihydroartemisinin Tablets for the Treatment of Discoid Lupus Erythematosus Dihydroartemisinin tablets, Hydroxychloroquine tablets - Discoid Lupus Erythematosus | Phase 2 | Not yet recruiting | Kunming Pharmaceuticals, Inc. | 100 | 2026-04-30 | 2026-04-30 |
| A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2) Enpatoran, Placebo, Standard of care (SoC) - Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus | Phase 3 | Recruiting | EMD Serono Research & Development Institute, Inc. | 202 | 2026-04-01 | 2026-10-06 |
| A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease Enpatoran, Placebo, Standard of care (SoC) - Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE) | Phase 3 | Recruiting | EMD Serono Research & Development Institute, Inc. | 202 | 2026-03-10 | 2026-10-06 |
| A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE) IMVT-1402, Placebo - Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus | Phase 2 | Active not recruiting | Immunovant Sciences GmbH | 56 | 2025-02-19 | 2026-08-28 |
| A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus Anifrolumab, Placebo - Cutaneous Lupus Erythematosus | Phase 3 | Active not recruiting | AstraZeneca | 339 | 2024-06-29 | 2026-07-29 |
| Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus Ruxolitinib 1.5% cream, Application without occlusion in Area 1, Application under occlusion at night in Area 2 - Discoid Lupus Erythematosus | Phase 2 | Recruiting | Innovaderm Research Inc. | 20 | 2024-04-19 | 2025-03-24 |
| A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus BIIB059 (litifilimab) - Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus | Phase 3 | Enrolling by invitation | Biogen | 306 | 2023-10-03 | 2026-08-04 |
| A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus BMS-986326, Placebo for BMS-986326 - Lupus | Phase 1 | Completed | Bristol-Myers Squibb | 45 | 2023-09-21 | 2026-05-26 |
| Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus Placebo, Daxdilimab - Discoid Lupus Erythematosus | Phase 2 | Terminated | Amgen | 72 | 2022-12-29 | 2026-05-14 |
| The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE) M5049 low dose, M5049 medium dose, M5049 high dose - Systemic Lupus Erythematosus | Phase 2 | Active not recruiting | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 381 | 2022-09-16 | 2026-10-15 |
| A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus Litifilimab, Placebo - Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus | Phase 2 / Phase 3 | Active not recruiting | Biogen | 450 | 2022-09-13 | 2026-10-23 |
| Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus Ruxolitinib - Discoid Lupus Erythematosus | Phase 2 | Completed | University of Rochester | 10 | 2022-05-04 | 2025-05-20 |
| The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW) Enpatoran low dose, Enpatoran medium dose, Enpatoran high dose - Systemic Lupus Erythematosus | Phase 2 | Completed | EMD Serono Research & Development Institute, Inc. | 456 | 2022-03-31 | 2025-12-01 |
| Topical Nicotinamide in Treatment of DLE Nicotinamide Topical - Discoid Lupus Erythematosus | Early Phase 1 | Completed | Al-Azhar University | 60 | 2022-03-01 | 2022-10-25 |
| A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Deucravacitinib, Placebo - Lupus Erythematosus, Discoid, Lupus Erythematosus, Subacute Cutaneous | Phase 2 | Active not recruiting | Bristol-Myers Squibb | 74 | 2021-07-12 | 2025-09-10 |
| A Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus Secukinumab - Discoid Lupus Erythematosus | Phase 2 | Withdrawn | Massachusetts General Hospital | 2019-09-01 | 2021-09-08 | |
| Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus. Delgocitinib cream, Delgocitinib cream vehicle - Discoid Lupus Erythematosus | Phase 2 | Terminated | LEO Pharma | 27 | 2019-07-09 | 2025-03-06 |
| Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Tofacitinib citrate - Discoid Lupus Erythematosus, Systemic Lupus Erythematosus | Early Phase 1 | Terminated | Tufts Medical Center | 5 | 2017-04-03 | 2022-01-21 |
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Lupus Erythematosus, Cutaneous (22) · Lupus Erythematosus, Systemic (14) · Alopecia (1) · Connective Tissue Diseases (1) · Dermatitis, Atopic (1) · Immune System Diseases (1) · Lichen Planus (1) · Lupus Nephritis (1) · Lupus Vasculitis, Central Nervous System (1) · Skin Diseases (1)
Skin and Connective Tissue Diseases (42) · Connective Tissue Diseases (41) · Skin Diseases (41) · Lupus Erythematosus, Cutaneous (20) · Immune System Diseases (15) · Autoimmune Diseases (14) · Autoimmune Diseases of the Nervous System (1) · Brain Diseases (1) · Cardiovascular Diseases (1) · Central Nervous System Diseases (1) · Central Nervous System Infections (1) · Central Nervous System Viral Diseases (1) · Cerebrovascular Disorders (1) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (1) · Dermatitis (1)
Blood Specimen Collection (2) · Etanercept (2) · Standard of Care (2) · Urine Specimen Collection (2) · pimecrolimus (2) · ruxolitinib (2) · 4-(9-(tetrahydrofuran-3-yl))-8-(2,4,6-trifluorophenylamino)-9H-purin-2-ylaminocyclohexan-1-ol (1) · Alitretinoin (1) · Betamethasone Valerate (1) · CC-11050 (1) · Hydroxychloroquine (1) · Lasers, Dye (1) · Niacinamide (1) · R333 (1) · Salicylic Acid (1)
EMD Serono Research & Development Institute, Inc. (4) · Amgen (3) · Biogen (3) · Astion Pharma A/S (2) · Bristol-Myers Squibb (2) · Janssen Research & Development, LLC (2) · Al-Azhar University (1) · AstraZeneca (1) · Beeline Medicines Corporation (1) · Celgene (1) · Chulalongkorn University (1) · Florida Academic Dermatology Centers (1) · Gilead Sciences (1) · Human Genome Sciences Inc., a GSK Company (1) · Immunovant Sciences GmbH (1)
United States (31) · Germany (14) · Poland (13) · Bulgaria (10) · Argentina (9) · Spain (9) · Taiwan (9) · Brazil (8) · Canada (8) · China (7) · France (7) · Mexico (7) · South Korea (7) · United Kingdom (7) · Australia (6)
Ahmed Hassan Nouh, MD (1) · Amy McMichael, MD (1) · Andrew G Franks, Jr., MD (1) · Anna Haemel, MD (1) · Annegret Kuhn, Prof. Dr. (1) · Behrooz Barikbin, M.D. (1) · Christopher T Richardson, MD, PhD (1) · Daniel Magilavy, MD (1) · David Rosmarin, MD (1) · David Wofsy, MD (1)
PMID 33687069, PMID 28118537, PMID 42107374, PMID 42107375
2023 (2), 2025 (2), 2015 (1), 2018 (1)